Infasurf®(Calfactant) Aerosol for Infants With Bronchiolitis-AERO-04

Bronchiolitis Clinical Trial

Official title:

Infasurf®(Calfactant) Aerosol for Infants With Bronchiolitis-AERO-04 A Pilot Study of Aerosol Surfactant for Bronchiolitis in Infants

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03748173
• Other study ID #: Aero-04
• Status: Terminated
• Phase: Phase 1
• Start date: January 12, 2019
• Est. completion date: October 21, 2020

Study information

• Verified date: October 2020
• Source: ONY
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Delivery of aerosolized Infasurf to bronchiolitis patients with who are not on assisted ventilation can provide sufficient delivery of Infasurf to small airways to improve ventilation and thereby shorten the duration of the respiratory illness.

Description:

This pilot clinical trial will compare "usual care" to aerosolized Infasurf. The study objective is to determine

1. Do bronchiolitis patients tolerate aerosolized Infasurf?

2. Does aerosolized Infasurf induce an improvement in respiration?

3. If it does how large a dose is required to observe a positive effect?

4. Is the positive effect transient, if so what is the range of duration of the effect?

5. Does retreatment also result and a positive response?

6. Does aerosolized Infasurf result in more rapid sustained improvement? is superior to.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: October 21, 2020
• Est. primary completion date: October 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 4 Months

Eligibility

Inclusion Criteria:

1. Infant = 4 months of age admitted to the PICU with the clinical diagnosis of bronchiolitis

2. Severe illness as reflected by a bronchiolitis score = 4 and requiring high flow nasal cannula or continuous positive airway pressure for respiratory support

3. Within 4 hours of PICU admission.

Exclusion Criteria:

1. Need for non-invasive BiPAP or invasive ventilation

2. Significant Co-morbidities

1. Chronic lung disease (evidenced by supplemental oxygen, home ventilation, or chronic diuretic therapy for CLD)

2. Unrepaired congenital heart disease

3. Immune compromise

4. Neuromuscular weakness

3. Tracheostomy

4. Influenza as the etiologic agent of bronchiolitis

5. Inability to stabilize the infant to a bronchiolitis score < 8

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Combination Product:
• Aerosolized Infasurf
Infants randomized to aerosol treatment will receive Infasurf® aerosol at a rate of 12 ml/hour (the maximal rate using the Solaris CAG). The initial treatment will be for 60 minutes, with reevaluation every 30 minutes thereafter, with a maximum dose of 6 mL/Kg body weight or 2 hours of aerosolization. Treatment will be stopped after 60 minutes (and subsequently at 30-minute intervals) if a 2 point reduction in bronchiolitis score or a score = 4 is achieved. Treatment will also be stopped at any time should there be evidence of other-than-transient deterioration in oxygenation or clinical status or for any serious adverse effect deemed by the infant's clinician to be possibly related to the drug administration.

Locations

Country	Name	City	State
United States	Children's Hospital of Richmond at VCU	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
ONY

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dose as Measured as duration of the therapy	To determine the optimal dose/duration of aerosolized Infasurf® in infants with bronchiolitis by aerosolizing Infasurf at 35mg/ml at a rate of 1.8 to 2.2 mls per minute until therapeutic response is achieved or the maximum amount of a single dose is reached.	24 hours post PICU admission
Primary	Improvement in Respiratory Status	Incidence of positive respiratory response to Infasurf® Aerosol defined as Bronchiolitis Clinical Score decreased by 2 points or to =4.	24 hours post PICU admission
Secondary	Need of Respiratory support	Incidence of need for non-invasive (BiPAP, NIV-NAVA) or invasive ventilation	24 hours post PICU admission